![CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]](https://medic.hrt.org//dailymed/images/1137a998-539c-4271-b092-990e9ef6f2e7/c004 hyb2.jpg)
| NDC | 10348-002-01, 10348-002-02 |
| Set ID | 1137a998-539c-4271-b092-990e9ef6f2e7 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | SMASHBOX BEAUTY COSMETICS, INC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER [] DIMETHICONE [] BUTYLENE GLYCOL [] PHENYL TRIMETHICONE [] PENTYLENE GLYCOL [] GLYCERYL STEARATE [] BEHENYL ALCOHOL [] TRIOCTYLDODECYL CITRATE [] POLYMETHYLSILSESQUIOXANE [] OCTYLDODECYL STEAROYL STEARATE [] PEG-40 STEARATE [] POLYGLYCERYL-10 PENTASTEARATE [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] PYRUS MALUS (APPLE) FRUIT EXTRACT [] SCUTELLARIA BAICALENSIS ROOT EXTRACT [] POLYQUATERNIUM-51 [] ACETYL HEXAPEPTIDE-8 [] TREHALOSE [] ORYZANOL [] OCTYLDODECYL NEOPENTANOATE [] UREA [] POLYGLYCERYL-6 POLYRICINOLEATE [] PROPYLENE GLYCOL LAURATE [] GLYCYRRHETINIC ACID [] TOCOPHERYL ACETATE [] SUCROSE [] GLYCERIN [] SODIUM STEAROYL LACTYLATE [] CAFFEINE [] LINOLEIC ACID [] CHOLESTEROL [] LECITHIN [] SQUALANE [] SODIUM PCA [] ISOPROPYL TITANIUM TRIISOSTEARATE [] PROPYLENE GLYCOL STEARATE [] STEARIC ACID [] POLYSORBATE 20 [] SORBITAN LAURATE [] XANTHAN GUM [] ALUMINUM HYDROXIDE [] SODIUM HYALURONATE [] SILICA [] DISODIUM EDTA [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] SODIUM DEHYDROACETATE [] CHLORPHENESIN [] PHENOXYETHANOL [] [+/- TITANIUM DIOXIDE (CI 77891) [] ZINC OXIDE (CI 77947) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAMERA READY 5 IN 1 BEAUTY BALM SPF 35
octinoxlate, octisalate, oxybenzone, titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10348-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.0 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.5 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.1 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DOCOSANOL (UNII: 9G1OE216XY) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) PEG-40 STEARATE (UNII: ECU18C66Q7) WHEAT GERM (UNII: YR3G369F5A) CUCUMBER (UNII: YY7C30VXJT) APPLE (UNII: B423VGH5S9) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL) TREHALOSE (UNII: B8WCK70T7I) GAMMA ORYZANOL (UNII: SST9XCL51M) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) UREA (UNII: 8W8T17847W) PROPYLENE GLYCOL MONOLAURATE (UNII: M4AW13H75T) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SUCROSE (UNII: C151H8M554) GLYCERIN (UNII: PDC6A3C0OX) CAFFEINE (UNII: 3G6A5W338E) LINOLEIC ACID (UNII: 9KJL21T0QJ) CHOLESTEROL (UNII: 97C5T2UQ7J) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SQUALANE (UNII: GW89575KF9) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) PROPYLENE GLYCOL MONOSTEARATE (UNII: F76354LMGR) STEARIC ACID (UNII: 4ELV7Z65AP) POLYSORBATE 20 (UNII: 7T1F30V5YH) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10348-002-01 1 in 1 CARTON 1 NDC:10348-002-02 30 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2011 Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 205952385 manufacture Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Aramis Inc. 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Bristol 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 618107429 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations Estee Lauder Kabushiki Kaisha 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture
